SchizophreniaNCT00224380
Medication Adherence in Older Adults With Serious Mental Illness
A study testing Using Medications Effectively in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of this pilot study is to learn about how well older people with serious mental illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major depression) follow prescribed medication regimens, and to evaluate a manualized intervention designed to enhance medication management skills and… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Depression
- What is being tested?
- Using Medications Effectively
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in Rehabilitation and Health Care for Older People with SMI Serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression) and functional impairment Receiving mental health services for 3 months or more Age 50 or older Ability to provide informed consent or guardian consent -
Who cannot join
- Currently residing in an institution Psychiatric illness caused by co-morbid medical condition Dementia or score<20 on Mini Mental State Exam
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Council of Nashua
Nashua, New Hampshire, 03063
About this study
Official title: Medication Adherence in Older Adults
The goal of this pilot study is to learn about how well older people with serious mental illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major depression) follow prescribed medication regimens, and to evaluate a manualized intervention designed to enhance medication management skills and adherence, the Using Medications Effectively program. The following four hypotheses will be tested:
- Medication adherence will be associated with several variables including insight, memory, medication management skill, knowledge about medications, attitudes about medications.
- People who receive the program will have better medication adherence compared to those who do not receive the program as measured by pill counts.
- People who receive the program will develop better medication management skills compared to those who do not receive the program.
Read the detailed description
Individuals who are already participating in a study of a combined skills training and health care management intervention for older people with serious mental illness are invited to join this study. Half of the individuals have already been randomly assigned to receive the intervention and half have already been randomly assigned to continue receiving their usual care. The people receiving the intervention receive the skills training module, Using Medications Effectively, in 8 group sessions over 8 weeks. The module includes information about common medications used for psychiatric and medical illnesses; training on using devices to help take medications properly; and instruction on strategies to help incorporate medication taking into a daily routine. A trained research assistant conducts pill counts and interview sessions with all participants after they sign an informed consent form, 8 weeks later, and 3 months after the second interview.
- Conditions
- Schizophrenia, Bipolar Disorder, Depression
- Being tested
- Using Medications Effectively
- Keywords
- Serious mental illness, medication adherence
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Medications EffectivelyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence based on pill counts
Secondary outcomes (1)
Medication management ability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJul 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP, National Alliance for Research on Schizophrenia and Depression
- Investigators
- Sarah I Pratt, PhD, Principal investigator, Assistant Professor in Psychiatry, Dartmouth Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224380
- Sponsor's protocol ID
- MA200316456
- Status last verified
- Sep 2009
- First submitted
- 15 Sep 2005
- Last updated
- 23 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence in Older Adults
- ClinicalTrials.gov ID
- NCT00224380
- Acronym / sponsor ID
- MA200316456
- Conditions
- Schizophrenia, Bipolar Disorder, Depression
- Keywords
- Serious mental illness, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Janssen, LP, National Alliance for Research on Schizophrenia and Depression
- Study start
- Jul 2003
- Study completion
- Feb 2005
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to learn about how well older people with serious mental illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major depression) follow prescribed medication regimens, and to evaluate a manualized intervention designed to enhance medication management skills and adherence, the Using Medications Effectively program. The following four hypotheses will be tested:
- Medication adherence will be associated with several variables including insight, memory, medication management skill, knowledge about medications, attitudes about medications.
- People who receive the program will have better medication adherence compared to those who do not receive the program as measured by pill counts.
- People who receive the program will develop better medication management skills compared to those who do not receive the program.
Detailed description
Individuals who are already participating in a study of a combined skills training and health care management intervention for older people with serious mental illness are invited to join this study. Half of the individuals have already been randomly assigned to receive the intervention and half have already been randomly assigned to continue receiving their usual care. The people receiving the intervention receive the skills training module, Using Medications Effectively, in 8 group sessions over 8 weeks. The module includes information about common medications used for psychiatric and medical illnesses; training on using devices to help take medications properly; and instruction on strategies to help incorporate medication taking into a daily routine. A trained research assistant conducts pill counts and interview sessions with all participants after they sign an informed consent form, 8 weeks later, and 3 months after the second interview.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in Rehabilitation and Health Care for Older People with SMI Serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression) and functional impairment Receiving mental health services for 3 months or more Age 50 or older Ability to provide informed consent or guardian consent -
Key exclusion criteria (2 listed)
- Currently residing in an institution Psychiatric illness caused by co-morbid medical condition Dementia or score<20 on Mini Mental State Exam
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using Medications Effectively | Behavioural | – |
Primary outcome
Medication adherence based on pill counts
1 secondary outcome
Medication management ability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah I Pratt, PhD principal investigator
Assistant Professor in Psychiatry, Dartmouth Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Medications Effectively in people with Schizophrenia and Bipolar Disorder, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence based on pill counts. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009.